This week San Francisco based blockchain and IoT Cloud platform start-up Chronicled announced achievement of 21 CFR Part 11 Certification for its latest Micro-Temperature Logging application which is the U.S. Food and Drug Administration (FDA) regulatory framework for the management of storage of electronic records and signatures. The 21 CFR Part 11 Certification is an oversight of controls, audits, validation, and digital signatures considered trustworthy, reliable, and equivalent to paper records.
In late September, Supply Chain Matters provided highlights of an MIT Enterprise Forum of Cambridge symposium discussing future development of Blockchain technology within supply chain management business process applications. Among the consensus observations from invited panelists was that like RFID technology, Blockchain can facilitate end-to-end supply chain visibility when applied to well defined use cases. Two panelists, including the co-founder and Chief Product Officer of Chronicled, had observed that government regulators, rather than having a cynical view of this new technology, were quite interested in understanding whether Blockchain could alleviate current regulatory pain points among regulated supply chains, and at the same time, make oversight of such supply chains far easier to monitor for integrity. Rather than dismissing the technology as-yet another hyped concept, industry supply chain teams and governmental regulators were more inclined to investigate and evaluate initial use cases.
This certification allows this technology provider the opportunity to provide its developed Temperature Loggers to businesses distributing temperature sensitive products, often referred to as Cold Chain, across the U.S. and overseas distribution channels. As the announcement points out, the integrity of the cold chain is crucial to certain pharmaceuticals, biologics, vaccines as well as other products such as food and specialty chemicals.
The company’s described second-generation micro temp-logger combines Near Field Communications (NFC) hardware with a secure Cloud-based service or optional blockchain enabled back-end logger to log and transact each temperature data point along the value or distribution chain. The announcement indicates:
“This data storage method, in which each data point is recorded on-chain within an immutable “block”, makes the product’s temperature history 100% secure and untamperable. As a result, regulators and end-customers no longer need to worry about edited, modified, or deleted records in the event of an investigation.”
Supply Chain Matters has highlighted this announcement to our readers because it provides evidence that regulators are indeed more willing to consider NFC, Blockchain and IoT enabled technologies as part of 21 CFR Part 11 processes. We believe that Chronicled being a founding member of the Trusted IoT Alliance with a mission of creating open source standards to connect IoT and Blockchain likely had special significance for regulators.
Obviously, Blockchain remains as an emerging technology and ongoing pilots and proof-of-concept deployments will provide additional learning and insights on wider scale adoption across industry segments. As previously observed and highlighted in the MIT Enterprise Forum symposium, with any newly deployed technology, standards are fundamental as is interoperability with current B2B Business Networks. Ongoing product innovation such as that from Chronicled, IBM, Oracle and SAP will lead to more industry-specific pilot deployments addressing industry needs such as cold chain, food safety and item level integrity monitoring and perhaps soon, more trusted levels of end-to-end supply chain visibility. The area of open standards remains an ongoing need but none the less. Industry pilots are working towards developing such standards.
More than any previous announced technologies, the combination of IoT, Blockchain and Cloud-based platforms have considerably more viable supply chain management opportunities. This week’s announcement is yet another indicator that even regulators have taken an interest.
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